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  1. Jobs and Training at FDA

Title 21 Job Opportunities

The 21st Century Cures Act was enacted on December 13, 2016 and Section 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products. The FY23 Food and Drug Omnibus Reform Act expanded this authority further amending Title 21 to include cross-cutting operational positions and individuals that support the development review and regulation of food and cosmetics in addition medical products. (codified into Title 21 of the United States Code (21 US Code 379d-3a).

The positions listed below are being filled under Title 21. The candidate selected for these positions will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here  

Title 21 Open Vacancies

Deputy Commissioner for Human Foods

The Office of the Commissioner is recruiting for a Deputy Commissioner for Human Foods to report directly to the Commissioner and serve as a clear line of authority over the entire Human Foods portfolio which presently include the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy & Response, and certain human foods-related components of the Office of Regulatory Affairs (ORA).

Infant Formula Cadre Supervisor 

The Office of Regulatory Affairs (ORA), Office of Human and Animal Food Operations (OHAFO), Office of Human and Animal Food Operations East (HAF-E) is recruiting for a Infant Formula Cadre Supervisor. 

Division Director 

The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for a Division Director. As a Division Director, the incumbent oversees a highly skilled staff that detects safety signals and assesses safety-related issues for all marketed drug and therapeutic biologic products. In this capacity, the Division uses a variety of surveillance tools and data sources to provide scientific and clinical evaluation. 

Chief Critical Foods Officer 

The Center for Food Safety and Applied Nutrition (CFSAN), Office of the Center Director (OCD) is recruiting for a Chief Critical Foods Officer reporting to the CFSAN director and will play a leadership role in establishing the Office of Critical Foods. The Office of Critical Foods will have responsibility for the oversight, coordination, and facilitation of activities related to critical foods, the definition of which includes infant formula and medical foods. 

Senior Physician (Medical Officer) for Critical Foods 

The Center for Food Safety and Applied Nutrition (CFSAN), Office of Nutrition and Food Labeling (ONFL) is recruiting for a Senior Physician (Medical Officer) for Critical Foods to serve as a professional Physician who oversees, manages, organizes, and directs all operations, program segments, functions, and activities of the infant formula and medical foods staff, as carried out by the team leader and staff. 

Senior Advisor for Critical Foods Enforcement and Compliance 

The Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance (OC) is recruiting for a Senior Advisor for Critical Foods Enforcement and Compliance to provide in-depth expertise for all pertinent regulatory and scientific matters impacting infant formula and critical foods compliance and enforcement, including the Infant Formula and Medical Foods Compliance Program and related policies and procedures in the Center for Food Safety and Applied Nutrition. 

Food Safety Advisor for Critical Foods (Interdisciplinary Scientist) 

The Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Safety (OFS) Division of Dairy, Egg and Meat Products is recruiting for a Food Safety Advisor for Critical Foods (Interdisciplinary Scientist) to provide policy, scientific and technical advice and assistance related to the safety of milk and milk products, including infant formula. 

Senior Regulatory Counsel for Critical Foods 

The Center for Food Safety and Applied Nutrition (CFSAN), Office of Regulations and Policy (ORP) is recruiting for a Senior Regulatory Counsel for Critical Foods who is often delegated full responsibility for planning, scheduling, and implementing the development, analysis, and evaluation of priority regulatory and public health initiatives, documents, and projects. 

Branch Chief 

The Center for Drug Evaluation and Research (CDER), Office of Management (OM) is recruiting for a Branch Chief. As the ASB Branch Chief in the Division of Budget and Resource Management (DBRM) the incumbent assumes primary responsibility for ensuring that centralized acquisition services are provided to the Center’s Super Office and is a liaison with OAGS to ensure the timely execution of the Center’s budget. 

Lab Chief 

The Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review (OVRR), Division of Viral Products (DVP), Laboratory of Vector Borne Diseases (LVBD) is recruiting for a Lab Chief. The incumbent serves as the Lab Chief for the Laboratory of Vector Borne Diseases (LVBD) within the DVP and the OVRR and manages daily operations of the Lab. The incumbent is responsible for supervision, technical leadership, and guidance regulating products used for the diagnosis, prevention and treatment of emerging viral diseases. This position reports to the DVP Director. 

 

Deputy Division Director (DBV) 

The Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS) is recruiting for a Deputy Division Director (DBV). As Deputy Division Director (Supervisory Mathematical Statistician), the incumbent is responsible for planning, coordinating, and evaluating the administrative and technical programs and activities. 

Physician 

The Center for Biologics Evaluation and Research (CBER), Office of Vaccines Review and Research (OVRR), Division of Vaccines and Related Product Applications (DVRPA) is recruiting for a physician. The Physician conducts clinical reviews and requires a scientific medical knowledge of the infectious diseases and allergy and immunology diseases being treated. The incumbent makes judgement in evaluating adverse events; understanding of clinical trial design and determines whether products are safe and effective for human use. 

Regulatory Counsel 

The Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP) is recruiting for a Regulatory Counsel. As a Regulatory Counsel in the Divisions of Regulatory Policy (DRP) I-IV in the Office of Regulatory Policy (ORP), the incumbent is responsible for writing regulations, preparing responses to citizen petitions, petitions for stay of action, and/or petitions for reconsideration; drafting and commenting on legislation; and providing advice on the interpretations of the laws, regulations, and policies applicable to the FDA. 

Associate Director of Advanced Medical Products Manufacturing 

The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO) is recruiting for an Associate Director of Advanced Medical Products Manufacturing. 

Consumer Safety Officer 

The Office of the Commissioner (OC), Office of Policy, Legislation and International Affairs (OPLIA), Office of Global Policy and Strategy (OGPS), Office of Global Operations (OGO), India and China Office is recruiting for a Consumer Safety Officer. 

Consumer Safety Officer (Band C) 

The Office of the Commissioner (OC), Office of Policy, Legislation and International Affairs (OPLIA), Office of Global Policy and Strategy (OGPS), Office of Global Operations (OGO), India and China Office is recruiting for a Consumer Safety Officer. 

Super Office Director 

The Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) is recruiting for a Super Office Director. As the Super Office Director of OTP in CBER, the incumbent provides executive leadership to the six offices within the Super Office and to the Immediate Office of the Director (IOD) regarding the review of regulatory submissions for quality, safety and effectiveness, for the conduct of applied scientific research and relevant regulatory policy. 

Physician 

The Center for Biologics Evaluation and Research (CBER), Office of Therapuetic Products (OTP), Office of Clinical Evaluaiton (OCE), Division of Clinical Evaluation Hematology (DCEH) is recruitnig for a Physician. The Physician will serve as a clinical reviewer, with a specialty in Hematology, who is a reviewer and advisor to the Division Director and other Center senior staff for the evaluation of the safety and effectiveness of novel biologic cell and gene therapies, plasma derived protein therapeutics, certain medical devices, and other OTP regulated medical products. 

Lead Physician (Hematology) 

The Center for Biologics Evaluation and Research (CBER), Office of Therapuetic Products (OTP), Office of Clinical Evaluaiton (OCE), Division of Clinical Evaluation Hematology (DCEH) is recruitnig for a Lead Physician. The incumbent will serve as a Lead Physician, with a specialty in Hematology, who serves as a secondary reviewer and is one of the principal advisors to the Division Director and other Center senior staff for the evaluation of the safety and effectiveness of novel biologic cell and gene therapies, plasma derived protein therapeutics, certain medical devices, and other OTP regulated medical products. 

Regulatory Policy Analyst (OP) 

The Center for Devices and Radiological Health (CDRH), Office of Policy (OP) is recruiting for a Regulatory Policy Analyst. Reporting directly to the Deputy Director, the Regulatory Policy Analyst will be responsible for: drafting supporting statements for information collection requests as required per the Paperwork Reduction Act (PRA) for regulations, guidance documents and/or other requests for information (e.g., surveys), and collaborative document development within the center, specifically for medical devices and radiological health products; leading work groups to accomplish these responsibilities and objectives; coordinating with other Centers and Offices within the FDA; and analyzing public comments on such regulatory documents which could have PRA implications and implementing appropriate revisions to documents. 

Director, Division of User Fee Management 

The Center for Drug Evaluation and Research (CDER), Office of Management (OM) is recruiting for a Director, Division of User Fee Management. As the Director for the Division of User Fee Management (DUFM), the incumbent operates as a senior level manager providing leadership, oversight, and execution of responsibilities to obtain the resources necessary for the Center and Agency to achieve their mission of promoting and protecting public health. 

Business Informatics Specialist 

The Center for Drug Evaluation and Research (CDER), Office of Strategic Programs (OSP) is recruiting for a Business Informatics Specialist. As a Business Informatics Specialist, the incumbent performs a variety of complex activities to include business analysis, project management, communication to understand and document business needs, develop strategies to meet those needs, and execute informatics projects. 

Deputy Division Director - OPEQ/OCEA/DCEA3 

The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Clinical Evidence & Analysis (OCEA), Division of Clinical Evidence and Analysis 3 (DCEA3) is recruiting for a Deputy Division Director. The incumbent will assist the DCEA 3 Director in setting strategy, advancing initiatives, and ensuring the goals, priorities, and objectives of the Division align with those of OCEA, OPEQ, and the Center. 

Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist) 

The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting an Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist). As an Interdisciplinary Scientist (Biologist, Pharmacologist/Toxicologist), the incumbent is responsible for reviewing and evaluating drug applications and communicates conclusions with a multidisciplinary review team. The work will be performed within any of the pharmacology/toxicology or clinical drug review divisions located within OND. 

Senior Data Scientist 

The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Clinical Evidence and Analysis (OCEA), Division of Clinical Evidence and Analysis II (DCEA2) is recruiting for a Senior Data Scientist. As a Senior Data Scientist, the selected candidate will serve as a subject matter expert and provide administrative and technical oversight on the integration of in-depth data science knowledge into data analytic and visualization tools that will be utilized to support Office and Center leadership in making evidenced-based regulatory decisions concerning digital health devices, encompassing the entire product lifecycle. 

Senior Data Engineer 

The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ) ,Office of Clinical Evidence and Analysis (OCEA), Division of Clinical Evidence and Analysis II (DCEA2) is recruiting for a Senior Data Engineer. CEA is seeking innovative, forward thinking and driven Data Engineer(s) to develop, pilot, and implement various data analytics tools within CDRH, while collaborating with a team of Data Scientists, Data Engineers and Developers across the Office and Center and interfacing with contractors to accomplish these goals. 

Consumer Safety Officer 

The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Consumer Safety Officer. As a Consumer Safety Officer, the incumbent will serve as the regulatory manager/coordinator for an assigned group of office level programs. Activities may include coordination oversight of programs. 

Project Coordinator 

The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Project Coordinator. As a Project Coordinator, the incumbent directly supports the development and review of regulation of medical products. 

Consumer Safety Officer 

The Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) is recruiting for a Consumer Safety Officer. As a Consumer Safety Officer, the incumbent will serve as the regulatory manager/coordinator for an assigned group of office level programs. Activities may include coordination oversight of programs. 

Division Director

The Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE), Division of Clinical Evaluation Hematology (DCEH) is recruiting for a Division Director. This position reports to the Director of OCE. OTP is a newly established Super Office within CBER which is responsible for the continued safety, purity, potency, and effectiveness of cellular, tissue, and gene therapies, plasma protein therapeutics, and other products regulated by OTP.

Consumer Safety Officer (Investigator)

The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Bioresearch Monitoring Operations (OBIMO) is recruiting for multiple Consumer Safety Officers (Investigator). The Consumer Safety Officer (CSO) has demonstrated and is recognized for a high level of competence in the full range of establishments regulated within the OBIMO program such as: clinical investigators, nonclinical laboratory facilities, sponsors, contract research organizations, institutional review boards, post marketing adverse drug experience reporting, and risk evaluation and mitigation strategies. 

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